Are you prepared for the risk management requirements in ICH GCP E6 (R2)? This session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. We will review the key steps of the process: risk identification, assessment, control, review, reporting, management, and communication. Having an effective risk management program not only ensures compliance with the ICH GCP E6 R2 requirements, but also ensures continuous improvement strategies for your clinical trials. Practical take-aways will be shared along with sample tools.
Dr. Susan Leister, BS, MBA, PhD, CQA, CSSBB, Trainer, Barnett International